- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05823714
Venetoclax+Azacytidine+Modified BUCY Conditioning Regimen for Acute Myeloid Leukemia and Myelodysplastic Syndromes Undergoing Allo-HSCT
April 10, 2023 updated by: The First Affiliated Hospital of Soochow University
Venetoclax + Azacytidine Followed by Modified BUCY Conditioning Regimen for High-risk Myelodysplastic Syndromes (MDS) and High-risk or Relapsed/Refractory Acute Myeloid Leukemia (AML) Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
The purpose of this prospective, open-label, single-center study is to evaluate the efficacy and safety of VEN-AZA (venetoclax and azacytidine) followed by modified BUCY (busulfan and cyclophosphamide) as conditioning regimen for high-risk myelodysplastic syndrome (MDS) and high-risk or relapsed/refractory acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is the only potentially curative therapy for patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML).
However, relapse remains a leading cause for treatment failure after hematopoietic cell transplantation (HCT) in patients, optimization of conditioning regimen can improve prognosis and decrease relapse.
Abnormal gene methylation is common in AML and MDS patients.
Azacytidine is a DNA methylation transferase inhibitor that can re-express tumor suppressor genes in leukemia cells.
Venetoclax is a selective BCL-2 inhibitor, which has antitumor activity against a variety of hematological malignancies.
The combination of the two drugs show a synergistic anti-tumor effect.
The objective of this study is to evaluate the safety and efficacy of VEN-AZA regimen followed by Allo-HSCT in the treatment of high-risk MDS and high-risk or relapsed/refractory AML.
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaowen Tang, MD
- Phone Number: +86-512-67781851
- Email: xwtang1020@163.com
Study Contact Backup
- Name: Depei Wu, MD
- Phone Number: +86-512-67781851
- Email: wudepei@163.com
Study Locations
-
-
Jiangsu
-
Suzhou, Jiangsu, China, 215006
- Recruiting
- The First Affiliated Hospital of Soochow University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 8 to 65 years;
- Diseases must be MDS and AML; high-risk MDS: int-2 risk, high risk by the IPSS; IPSS-R int-risk (> 3.5 points), high risk, very high risk; high risk,very high risk by the WPSS; high-risk or relapsed/refractory AML: (1) age≥60 years; (2) High white blood cell count at first diagnosis (WBC≥100*10^9/L); (3) secondary AML (previous history of MDS, myeloproliferative disease, or treatment-related AML, etc.); (4) Complicated with extramedullary leukemia, such as central nervous system leukemia, granulocytic sarcoma, hepatosenomegaly; (5)high risk factors and relapsed/refractory AML(reference 2022-AML-ELN guideline)(6)not in remission or ≥CR2 before transplantation;
- Must need a bone marrow transplant;
- Must have the ability to observe the efficacy and events;
- Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed.
Exclusion Criteria:
- Age <8 or >65 years;
- Uncontrolled bacterial, viral, fungal, or other infection before conditioning regimen;
- Pregnant or lactating females;
- Current participation in another clinical trial;
- Contra-indication to one of the drug of the regimen;
- Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VEN+AZA+Modified BUCY
|
Venetoclax: 200mg/day*7days(It should be combined with triazole antifungal drugs). Azacytidine: 75mg/ m²/day*7days. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
disease-free survival (DFS)
Time Frame: 3 years after transplantation
|
It is measured from the time from randomization to the first of relapse or death.
|
3 years after transplantation
|
overall survival (OS)
Time Frame: 3 years after transplantation
|
It is measured from the time of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.
|
3 years after transplantation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
veno-occlusive disease (VOD)
Time Frame: 3 years after transplantation
|
incidence of veno-occlusive disease (VOD) events (refer to modified Seattle Criteria of VOD)
|
3 years after transplantation
|
graft-versus-host disease (GvHD)
Time Frame: 3 years after transplantation
|
incidence and severity of acute (aGvHD) and chronic graft-versus-host disease (cGvHD) (aGvHD refer to Glucksberg Criteria and cGvHD refer to the National Institutes of Health Consensus)
|
3 years after transplantation
|
transplant related mortality (TRM)
Time Frame: 3 years after transplantation
|
cumulative incidence of transplant related mortality
|
3 years after transplantation
|
Regimen related toxicity
Time Frame: 3 years after transplantation
|
Number of participants with conditioning regimen related toxicity
|
3 years after transplantation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Depei Wu Wu, MD, The First Affiliated Hospital of Soochow University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2022
Primary Completion (Anticipated)
January 20, 2025
Study Completion (Anticipated)
January 20, 2026
Study Registration Dates
First Submitted
February 27, 2023
First Submitted That Met QC Criteria
April 10, 2023
First Posted (Actual)
April 21, 2023
Study Record Updates
Last Update Posted (Actual)
April 21, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VA+mBUCY-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Myeloid Leukemia
-
University of PennsylvaniaActive, not recruitingAcute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia, Refractory | Acute Myeloid Leukemia, PediatricUnited States
-
Terrence J Bradley, MDImago BioSciences, Inc., a subsidiary of Merck & Co., Inc., (Rahway, New...RecruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Acute Myeloid Leukemia, in RelapseUnited States
-
National Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Recurrent Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
Bhavana BhatnagarCTI BioPharmaCompletedRecurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Therapy-Related Acute Myeloid LeukemiaUnited States
-
Washington University School of MedicineWithdrawnRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
C. Babis AndreadisGateway for Cancer Research; AVEO Pharmaceuticals, Inc.TerminatedAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
Massachusetts General HospitalExelixisCompletedRefractory Acute Myeloid Leukemia | Relapsed Acute Myeloid LeukemiaUnited States
-
Jacqueline Garcia, MDEli Lilly and CompanyCompletedCombination Merestinib and LY2874455 for Patients With Relapsed or Refractory Acute Myeloid LeukemiaRelapsed Adult Acute Myeloid Leukemia | Refractory Adult Acute Myeloid LeukemiaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Recurrent Adult Acute Myeloid Leukemia | Secondary Acute Myeloid Leukemia | Refractory Acute Myeloid LeukemiaUnited States
-
University of NebraskaNational Cancer Institute (NCI)Active, not recruitingSecondary Acute Myeloid Leukemia | Therapy-Related Acute Myeloid Leukemia | Adult Acute Myeloid LeukemiaUnited States
Clinical Trials on VEN+AZA+Modified BUCY
-
The First Affiliated Hospital of Soochow UniversityRecruitingAcute Lymphoblastic Leukemia | Allogeneic Hematopoietic Stem Cell TransplantationChina
-
Shanghai Jiao Tong University School of MedicineRecruitingRefractory Acute Myeloid LeukemiaChina
-
Janssen Research & Development, LLCActive, not recruitingAcute Myeloid Leukemia | Myelodysplastic Syndromes | Chronic Myelomonocytic LeukemiaUnited Kingdom, France, Korea, Republic of, Spain
-
University of LeipzigAbbVie; University Hospital Leipzig, Hematology Diagnostics Laboratory; University...RecruitingAcute Myeloid Leukemia (AML)Germany
-
The First Affiliated Hospital of Soochow UniversityThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical... and other collaboratorsUnknownAcute Myeloid Leukemia | Allogeneic Hematopoietic Stem Cell Transplantation | ConditioningChina
-
Immune-Onc TherapeuticsCalifornia Institute for Regenerative Medicine (CIRM)RecruitingCMML | AML With Monocytic DifferentiationUnited States
-
Janssen Research & Development, LLCRecruitingLeukemia, Myeloid, AcuteUnited States, Germany, Italy, France, Australia, Spain, United Kingdom
-
Shanghai Mental Health CenterUnknownMajor Depressive DisorderChina